Boniva


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Related to Boniva: Boniva Injection

ibandronate

(i-ban-dro-nate) ,

Boniva

(trade name)

Classification

Therapeutic: bone resorption inhibitors
Pharmacologic: biphosphonates
Pregnancy Category: C

Indications

Treatment/prevention of postmenopausal osteoporosis.

Action

Inhibits resorption of bone by inhibiting osteoclast activity.

Therapeutic effects

Reversal/prevention of progression of osteoporosis with decreased fractures.

Pharmacokinetics

Absorption: 0.6% absorbed following oral administration (significantly ↓ by food).
Distribution: Rapidly binds to bone.
Protein Binding: 90.9–99.5%.
Metabolism and Excretion: 50–60% excreted in urine; unabsorbed drug is eliminated in feces.
Half-life: PO—10–60 hr; IV—4.6–25.5 hr.

Time/action profile

ROUTEONSETPEAKDURATION
POunknown0.5–2 hrup to 1 mo
IVunknown3 hrup to 3 mo

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Abnormalities of the esophagus which delay esophageal emptying (i.e. strictures, achalasia);Uncorrected hypocalcemia;Inability to stand/sit upright for at least 60 min;CCr <30 mL/min.
Use Cautiously in: History of upper GI disorders;Concurrent use of NSAIDs or aspirin;Invasive dental procedures, cancer, receiving chemotherapy or corticosteroids, poor oral hygeine, periodontal disease, dental disease, anemia, coagulopathy, infection, or poorly-fitting dentures (may ↑ risk of jaw osteonecrosis); Obstetric: Use only if potential benefit outweighs risks to mother and fetus; Lactation: Lactation; Pediatric: Children <18 yr (safety not established); Geriatric: Consider age related ↓ in body mass, renal and hepatic function, concurrent disease states and drug therapy.

Adverse Reactions/Side Effects

Gastrointestinal

  • diarrhea (most frequent)
  • dyspepsia (most frequent)
  • dysphagia
  • esophageal cancer
  • esophagitis
  • esophageal/gastric ulcer

Musculoskeletal

  • musculoskeletal pain (most frequent)
  • pain in arms/legs (most frequent)
  • femur fractures
  • osteonecrosis (primarily of jaw)

Respiratory

  • asthma exacerbation

Miscellaneous

  • anaphylaxis (life-threatening)
  • injection site reactions

Interactions

Drug-Drug interaction

Calcium-, aluminum-, magnesium-, and iron- containing products, including antacids ↓ absorption (ibandronate should be taken 60 min before).Concurrent use of NSAIDs including aspirin, may ↑ risk of gastric irritation.Milk and other foods ↓ absorption.

Route/Dosage

Oral (Adults) 150 mg once monthly.
Intravenous (Adults) 3 mg every 3 mo.

Availability (generic available)

Tablets: 150 mg
Injection: 3 mg/3 mL in prefilled single-use syringe

Nursing implications

Nursing assessment

  • Osteoporosis: Assess patients for low bone mass before and periodically during therapy.
  • Intravenous: Monitor for signs and symptoms of anaphylactic reactions (swelling of face, lips, mouth or tongue; trouble breathing; wheezing; severe itching; skin rash, redness or swelling; dizziness or fainting; fast heartbeat or pounding in chest; sweating) during therapy. Discontinue injection immediately and begin supportive treatment if symptoms occur.
  • Lab Test Considerations: Assess serum calcium before and periodically during therapy. Hypocalcemia and vitamin D deficiency should be treated before initiating ibandronate therapy.
    • May cause ↓ total alkaline phosphatase levels.
    • May cause hypercholesterolemia.

Potential Nursing Diagnoses

Risk for injury (Indications)

Implementation

  • Oral: Administer first thing in the morning with 6–8 oz plain water 30 min before other medications, beverages, or food. Tablet should be swallowed whole; do not break, crush, or chew.
    • Once-monthly tablet should be administered on the same date each month.
  • Intravenous Administration
  • Intravenous: Administer using prefilled syringe. Do not administer solution that is discolored or contains particulate matter. Administer IV only; other routes may cause tissue damage.
  • Rate: Administer as a 15–30 second bolus.
  • Y-Site Incompatibility: Do not administer with calcium-containing solutions or other IV drugs.

Patient/Family Teaching

  • Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D. Wait at least 60 min after administration before taking supplemental calcium and vitamin D.
    • Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
    • Inform patient that severe musculoskeletal pain may occur within days, months, or yr after starting ibandronate. Symptoms my resolve completely after discontinuation or slow or incomplete resolution may occur. Notify health care professional if severe pain occurs.
    • Instruct patient to notify health care professional if swallowing difficulties, chest pain, new or worsening heartburn, or trouble or pain when swallowing occurs; may be signs of problems of the esophagus.
    • Advise patient to inform health care professional of ibandronate therapy prior to dental surgery.
    • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.
  • Oral: Instruct patient on the importance of taking as directed, first thing in the morning, 60 min before other medications, beverages, or food. Ibandronate should be taken with 6–8 oz plain water (mineral water, orange juice, coffee, and other beverages decrease absorption). Do not chew or suck on tablet. If a dose is missed, skip dose and resume the next morning; do not double doses or take later in the day. If a once-monthly dose is missed and the next scheduled dose is >7 days away, take in the morning following the date it is remembered. Resume original schedule the following month. If the next dose is <7 days away, omit dose and take next scheduled dose. Do not discontinue without consulting health care professional.
    • Caution patient to remain upright for 60 min following dose to facilitate passage to stomach and minimize risk of esophageal irritation. Advise patient to stop taking ibandronate and contact health care professional if symptoms of esophageal irritation (new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn) occur.
  • Intravenous: Advise patient that IV doses should not be administered sooner that every 3 mo. If a dose is missed, have health care professional administer as soon as possible; next injection should be scheduled 3 mo from last injection.

Evaluation/Desired Outcomes

  • Prevention of or decrease in the progression of osteoporosis in postmenopausal women. Discontinuation after 3–5 years should be considered for women with low risk for fractures.

Boniva

(bō-nē′və)
A trademark for the drug ibandronate sodium.
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References in periodicals archive ?
Research from Wellpoint suggested there are higher rates of femur fractures using Boniva, a drug for osteoporosis jointly marketed by GlaxoSmithKline and Roche, than its rivals.
Osteonecrosis (bone death) of the jaw, or ON], is a very rare complication of bisphosphonate drugs (including Actonel, Fosamax, Boniva, and Reclast) which, when it occurs, typically follows a tooth extraction or other trauma to the jaw, says Dr.
Some of the manufacturers of bisphosphonate therapies (Fosamax, Actonel, Boniva, and Reclast) issued statements pledging to continue to monitor reports of atypical fractures, but stand by the benefits of the therapies.
The study, published in the British Journal of Cancer, found that women who used bisphosphonate drugs, such as Fosamax, Boniva and Zomita, for more than two years had a nearly 40 percent reduction in risk as compared to those who did not, according to lead author Polly Newcomb, Ph.
In addition, Fosamax, Actonel and Boniva cause serious trouble because they stay in the bone indefinitely and disrupt the normal bone regeneration process forever
and Boniva are the nitrogen-containing oral bisphosphonates that are most likely to cause this condition.
Bisphosphonates are the active ingredient in widely prescribed osteoporosis medications such as Fosamax, Actonel and Boniva.
Cases of osteochemone- crosis have been found among patients taking nitrogen-based bisphos- phonate medicines, including Fosamax, Actonel and Boniva and the IV cancer drugs Aredia and Zometa.
Food and Drug Administration approval to introduce generic versions of the allergy pill Clarinex, for which Sepracor owns patent rights, and Roche's osteoporosis drug Boniva.
Fosamax (alendronate), Actonel (risedronate) and Boniva (ibandronate) are approved for bot hthe prevention and treatment of postmenopausal osteoporosis; however, whereas Fosamax and Actonel have been shown to reduce hip and vertebral fractures, Boniva has only been shown to reduce the risk of vertebral fractures.
Nasdaq: MYL) today announced that it has launched Ibandronate Sodium Injection, 1 mg (base)/mL, packaged in 3 mg (base)/3 mL pre-filled glass syringes, which is the generic version of Hoffmann-La Roche's Boniva Injection.